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Clinical Trials in Spain / NCT05657704
Active, not recruiting Phase 4

Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol

NCT05657704 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Phase
Phase 4
Started
2022-10-05
Last updated
2026-08-19

Condition(s) studied

Post-surgical PainPain, AcutePostoperative Pain

Investigational drug(s) / intervention(s)

The patients in experimental group will be genotyped before surgery and treatment will be prescribed according to the CYP2D6 phenotype

The patients in experimental group will be genotyped before surgery and treatment will be prescribed according to the CYP2D6 phenotype: Treatment will be prescribed according to the CYP2D6 phenotype. Normal Metabolizers (NM): Tramadol 100 mg every 8 hour; Ultrarapid Metabolizers (UM): Tramadol 50 mg every 8 hours Intermediate and poor metabolizers (IM/PM): dexketoprofen 25 mg every 8 hours

Study summary

Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain.

Phase IV and low-intervention trial To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.

The main evaluation variable: This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Men or women over 18 years of age. * Patients scheduled for outpatient surgical extraction, under local anesthesia, of at least two impacted third molars, at least one of which will require bone removal. * Patients who agree to participate in the study and give written consent. Exclusion Criteria: * Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen. * Patients on treatment with bisphosphonates. * Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit. * Patients suffering from other uncontrolled diseases. * Pregnant or breastfeeding women. * Patients with contraindications for treatment with tramadol or dexketoprofen.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Hospital Universitario Puerta de Hierro Majadahonda Madrid
Hospital Universitario San Juan de Alicante Alicante Spain
Hospital General Universitario de Burgos y Clínica Colina Burgos Spain
Fundación para la Investigación Biomédica Hospital La Princesa Madrid Spain
Hospital Univesitario Ramón y Cajal Madrid Spain
Hospital Universitario Clínico San Carlos Madrid Spain
Hostpital Universitario Fundación Jiménez Díaz Madrid Spain
Hospital Universitaro La Paz Madrid Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05657704 on ClinicalTrials.gov ↗ ← All trials in Spain